The present invention relates generally to medical monitoring and alert systems, and more specifically to a medical monitoring and alert system for monitoring the status of therapeutic devices such as intravenous infusion pumps, ventilators, and patient warming devices and providing alert status information to remote caregivers via bi-directional wireless communications. The medical monitoring and alert system can also be used to control the operation of the therapeutic devices through wireless communications from a central monitoring system, monitor physiological parameters and provide bi-directional communications with an alert system.
Electronic devices for delivering a medical therapy are well known in the art. Among these devices are intravenous infusions pumps (IV Pumps), ventilator support devices (ventilators), hemodialysis machines, and patient warming/cooling systems.
Electronic therapeutic devices frequently include an audio or visual alarm or alert system to provide an indication to a caregiver when attention is required. In some cases, these devices also include an analog output port that can be connected to a simple xe2x80x9cNurse Callxe2x80x9d system, such as a remote audio alarm or a lamp illuminated outside the patients"" room. More recently, therapeutic devices have included an RS-232 serial port for communicating various therapy status data and alarm data to an external system. The data is often transmitted to an existing computer network in a clinical setting, and frequently to computerized patient record devices to collect status information. While these known therapeutic devices are very effective in some applications, they also suffer from some notable disadvantages.
One problem associated with prior art patient monitor/therapeutic device combinations is that the devices are not sufficiently mobile for many clinical settings. In many cases, the patient monitors are large, non-mobile, fixed units. Those which are sufficiently small to allow for mobile applications are generally connected through an RS-232 port or other hard-wired communications port to an external network or other system. Whenever a patient must be moved, therefore, the monitor must be disconnected and reconnected at the new location. Furthermore, a patient cannot move throughout a care facility while being monitored. These units, therefore, are problematic in many clinical settings.
Another problem associated with prior art therapeutic devices is that they often include audio or visual alarms or alert signals that require the caregiver to be near the device when an emergency occurs. Visual and audio alert signals are generally sufficient when used in an intensive care unit or other closely watched hospital setting. In these environments, the caregiver is always within range of any alarms that the therapeutic device generates. These devices, however, are not sufficient for use in general clinical settings where a small number of nurses or other caregivers are monitoring a large number of patients, because visual and audio alert signals do not provide a means for notifying a remote caregiver of an alert situation.
Additionally, the alert or alarm signals coupled to prior art devices generally require a manual confirmation that an alert or alarm signal has been received. The confirmation may require the activation of a switch, a telephone call, or other manual input. In other cases, the alert or alarm signal is unidirectional. In these cases, the alarm or alert signal can continue indefinitely without receiving the response of a caregiver.
Furthermore, existing patient monitor/therapeutic device combinations generally cannot control the therapy delivered to a patient from a remote location. Therefore, when a change in a patient""s condition is detected, a caregiver must physically move to the patient""s bedside. This system is inefficient in many clinical settings where a limited number of personnel are monitoring and providing medical care to a number of patients.
There remains a need, therefore, for an integrated medical monitoring and alert system capable of optionally monitoring both the therapy delivered to and the physiological parameters of a mobile or ambulatory patient while providing an alarm or alert signal to remote caregivers. Therapy delivery, monitoring, and alert signal devices would preferably be coupled to the monitoring system via hardwired or wireless communications links, depending on the required application. Monitoring information would preferably be transmitted via a wireless communication link to allow for monitoring of mobile patients. The communications link would preferably also be bi-directional to provide a means for acknowledging the receipt of an alert or alarm signal, and therefore a means of determining that an alert condition has been attended to or resolved. Furthermore, bi-directional communications allow for remote control of therapy delivery and physiological monitoring parameters from an external device. Preferably, the medical monitoring system would include a patient monitor for monitoring and transmitting patient vital sign data, and a central monitoring system located at a nurse""s station or other centralized location to provide a remote monitor of patient therapy status and alert conditions. The central monitoring system would preferably also provide a storage location for maintaining a database of patient therapy status data, alert conditions, vital sign parameters, and therapy applied data to provide a total record of patient care. The central monitoring system would also preferably be linked to an overall hospital information system for maintaining overall patient records, which could include clinical data in addition to insurance data, physician data, pharmaceutical data, and other medical information.
Accordingly, it is an object of the invention to provide an integrated medical monitoring and alert system which can be used to monitor a medical therapy delivered to a patient and provide therapy status data, physiological data, and alert data to a remote caregiver via bi-directional communications.
It can be another object of the invention to provide a medical monitoring system optionally comprising physiological monitoring, therapy delivery, and alert devices which can be selectively configured to provide a customized system for a given medical monitoring situation.
It can be another object of the invention to provide a medical therapy delivery system linked bi-directionally to both monitoring and alert condition devices.
It can be another object of the invention to provide a medical monitoring system comprising a communications network which can include both wireless bi-directional links and hardwired links between therapy delivery, monitoring, storage and alert components such that each of the components of the system can selectively communicate with each of the other components of the system.
It can be another object of the invention to provide a medical monitoring system capable of monitoring a medical therapy delivered to mobile patients and capable of providing alert condition data to remote caregivers.
It can be another object of the invention to provide a bi-directional alert and monitoring system coupled to a therapy delivery system.
It will be understood by those skilled in the art that one or more aspects of this invention can meet certain objectives, while one or more other aspects meet certain other objectives. Each objective may not apply equally, in all instances, to every aspect of the invention. As such, the objects can be viewed in the alternative with respect to any one aspect of the present invention.
The medical monitoring system of the present invention preferably comprises a central monitoring system for monitoring the therapy and physiological status of a number of patients from a nurse""s station or other centralized monitoring location and at least one of a therapeutic delivery device, a local patient monitor for monitoring therapy and physiological parameters, and an integrated alert system for providing both patient physiological and therapy status data and alert condition data to remote caregivers. Communications between the various components of the system are preferably provided through a bi-directional communications network, thereby allowing interaction between any of the various components. For example, due to the bi-directional communication system, the alert system can notify the central monitoring system when an alert signal has been received, thereby assuring the clinical personnel at the central station that an alert condition is being attended to. Furthermore, in some embodiments of the invention, the central monitoring system can be used to select the output parameters of the therapeutic device. The patient monitor, central monitoring systems, and remote access devices are preferably coupled together through a bi-directional communications network comprising both a hardwired segment and a wireless segment. Each of the component parts of the system can communicate to another component of the system through a communications link, employing either the hardwired segment, the wireless segment, or both. Therefore, rapid delivery of therapeutic data, physiological parameters, and alert conditions can be communicated quickly through and even outside a care facility.
In operation, therapy status data from the therapeutic device such as an intravenous infusions pump (IV Pump), ventilator support device (ventilator), hemodialysis machine, or patient warning/cooling system, can be regularly communicated to the patient monitor through a communications port which can be linked to a wireless communication segment, an RS-232 serial connection, or other hardwired or wireless network connection. At the patient monitor, the therapy status data can be displayed, stored in memory, or both. The patient monitor can further transmit the therapy status data to the central monitoring system where the data, again, can be displayed, stored, or transmitted to a data storage system, as will be discussed below. Optionally, the patient monitor can also monitor, store, and transmit patient physiological parameters.
When a therapy alert condition occurs, a medical alert signal can be sent from the therapeutic device to the patient monitor. The patient monitor can also provide alert condition signals related to physiological conditions. The patient monitor preferably transmits the alert condition data to the central monitoring system along with patient physiological parameter information, and therapy status information as part of the normal data communications structure used to transmit this information. These medical alerts can be reviewed by a caregiver at the central monitoring system, or sent out automatically as selected by the user. The latter mode permits unattended medical alerts to be sent to remote caregivers when the central monitoring system is unmonitored.
The alert signal can be transmitted to an alert system which preferably comprises a number of remote access devices carried or located near caregivers. The remote access devices communicate bi-directionally with the central monitoring system. Preferably, therefore, once an alert signal has been received by a caregiver, an acknowledgement signal can be sent by the remote access device to the central monitoring system. In the event that no acknowledgement is received, the central monitoring system can alert additional caregivers until an acknowledgement is received and the alert condition is resolved. Although the remote access devices preferably comprise pagers, other devices including telephones, handheld computers, personal digital assistants (PDAs) and personal computers can also be used.
Preferably, the patient monitors and the central monitoring systems are each capable of storing patient therapy, patient physiological data, and alert status data for later retrieval and display by medical personnel. To ensure accurate entry and retrieval of stored patient data, the patient monitors, central monitoring systems, alert system remote access devices, and therapeutic devices can all include electronic data entry devices such as barcode scanners. The data entry devices can be used to identify the patient, the caregiver, medications, solutions, and devices. This identification information can be stored as part of an overall patient record database.
Furthermore, the information communicated to the central station from the therapeutic device is preferably shared with an auxiliary storage component or computerized database system such as hospital information system (HIS) programs and computers. This shared data allows other external systems to monitor and track this data for clinical record keeping and also for billing, central supply ordering, pharmacy tracking etc. Interaction with pharmacy computer systems allows for review of currently infused drugs and solutions to determine whether a combination of pharmaceuticals being delivered to the patient may be affecting the condition of the patient. Any detected alerts from these pharmacy computer programs could be linked back to the central station via the HIS and be supplied as an alert conditions triggering a signal to the remote access devices. Thus the caregiver would have rapid notification of potential complications as detected by these pharmacy systems.
In some embodiments of the invention, the therapeutic device can communicate directly with the central monitoring system. In these embodiments, the therapeutic device preferably communicates directly with the central monitoring system through the wireless segment of the communications network. The wireless communications capability can be added to the therapeutic device by means of commercially available RF communication modules or through a custom designed integral module coupled to the therapeutic device.
As noted above, because the communications technology used in this system is bi-directional, the central monitoring system can be used to remotely control the therapeutic device or the patient monitor in some applications. In these applications, the central monitoring system can be used to change the delivery parameters, reset alert conditions, select monitoring parameters, and provide delivery timing data. The ability to remotely control the therapeutic device and patient monitors increases efficiency in staff utilization and reduces time requirements in patient care. In these applications, all changes to the therapeutic device settings are part of the patient record. Therefore, all related status information can be presented as a complete patient trend record documenting the patients"" condition.
Because wireless bi-directional communications can be employed between the therapeutic device, a patient monitor, and a central monitoring system, the patient may be mobile while being safely monitored for both vital signs and therapeutic device status. Because patient mobility is important in recovery, all patients are encouraged to become mobile. The ability to monitor the vital signs and health of an ambulatory patient therefore offers a major advantage over prior art systems.
Other advantages and features of the invention, together with the organization and manner of operation thereof, will become apparent from the following detailed description when taken in conjunction with the accompanying drawings wherein like elements have like numerals throughout the drawings.